slightly off topic; long; info on crohns disease

[Guest guest]

group,

some latest info on crohns treatment out there. these are a little

long (they appear to be the full article). there are 2 articles

here. here goes:

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*New Biologic Option for Crohn's Disease Offers a Welcome Option, but

New

Complexity to a Condition That Health Plans Have Not Managed

Aggressively*

**

A recent Food and Drug Administration (FDA) approval of an infusible

drug

for the treatment of Crohn's disease brings a welcome option - and new

complexity — to a condition that health plans have not aggressively

managed.

On Jan. 14, manufacturers Biogen Idec, Inc. and Elan Corp. said that

the FDA

had granted their drug Tysabri (natalizumab) an additional indication

for

adults with moderate to severe Crohn's. The companies say the drug

will be

available to Crohn's patients later this month.

The drug was approved for multiple sclerosis (MS) in late 2004 but was

withdrawn from the market in February 2005 after reports of patients

in

clinical trials contracting progressive multifocal leukoencephalopathy

(PML), a viral infection of the brain that often causes death or

disability.

It was relaunched in July 2006, under a risk-management program.

According to the Crohn's & Colitis Foundation of America,

approximately

500,000 people have Crohn's, a chronic disorder that causes

inflammation of

the gastrointestinal tract.

" Despite the widely known disease prevalence and the incidence

statistics,

health plans have not placed Crohn's as an aggressive category for

active

management, " says Cichy, vice president of business

development of

commercial operations with Walgreens-Option Care. With Tysabri added

to the

mix of available therapies, though, insurers are already paying more

attention.

Crohn's treatments have historically been dominated by non-biologic

agents:

aminosalicylates (or 5-ASAs), corticosteroids, immunosuppressives and

antibiotics. " Not until Remicade was approved [in August 1998] was

there a

biologic option, " says Cichy. Another biologic tumor necrosis factor

(TNF)

inhibitor, Abbott Laboratories' Humira (adalimumab) , was approved in

February 2007 for Crohn's.

Cichy says that Walgreens' health plan customers take various

management

approaches to Crohn's.

" Step therapy is the most common tool, " he says, with various oral

agents

approved for first- and second-line therapy. According to

Cichy, " Prior

authorization edits are utilized less frequently. " With this

approach, some

cases may allow utilization of some drugs earlier than step therapy

may

prescribe, he says. Formularies are also an option that he has seen

in some

cases, but " as a general rule within specialty pharmacy for Crohn's,

this

has not been widely adopted. The relative lack of multiple products

within

the biologic space " has meant health plans are not aggressively

managing the

therapies in this way.

" Because of TNF inhibitors approved for Crohn's, we have been

managing the

therapies through a combination of policies, [prior authorization] and

reimbursement controls, " says Al Heaton, Pharm.D., director of

pharmacy at

BlueCross BlueShield of Minnesota, who adds that Tysabri has just

been added

to the plan's mix of therapies. " Locally, our gastroenterologists

have not

highly used the TNFs, " he adds.

Ed Pezalla, M.D., national medical director for Aetna Pharmacy

Management,

says that similar to other chronic diseases, the plan " does not manage

Crohn's. It makes available the specialists, medications and tools

needed to

treat patients. " The pharmacy and therapeutics committee on the

pharmacy

side and the clinical policy committee on the medical side " make

coverage

decisions based on the best available evidence, " he says. Medications

approved for Crohn's, including the biologics, are on formulary, he

adds,

and " if something is on the second tier and other therapies need to

be used

first, we may have a recommendation or something more strong like an

edit "

in place.

The approval of Tysabri for Crohn's highlights various challenges

that plans

and providers have in managing this condition.

For one thing, the diagnosis itself can be a problem, says Pezalla.

" Patients may present with chronic diarrhea, constipation and

abdominal

pain. It may take a while to get to a diagnosis. " Aetna, he says,

makes sure

that it has a gastroenterologist available in the network so patients

can

get referred there.

Patient adherence to long-term therapy in order to achieve and

maintain

remission may be an issue, says Cichy. " Maintaining medication

schedules can

be burdensome, " he contends. Crohn's patients are not on monotherapy

regimens in which they are taking one drug, but rather " polypharmacy

is

common within this patient population, " he says. There are multiple

agents,

including orals, injectables and infusibles, used to treat the

condition,

which " increases the burden to manage adherence to a regimen, " he

says. And

as with any disease state, patient compliance is crucial - Walgreens

data

show that noncompliant Crohn's patients face a five-fold increase in

the

chance of a relapse, Cichy says.

Because Crohn's is an inflammatory condition, says Cichy, " there

tends to be

a waxing and waning of the condition. It is a complex disease process

that

is rarely addressed by a single agent. "

Problems with nutrition may result in patients being hospitalized for

dehydration, says Pezalla. Side effects from the medication, including

flu-like illnesses and an increased risk of infection, may also be a

challenge for patients.

According to Cichy, " Another challenge that the approval brings to the

surface is that apart from Remicade, there is a lack of suitable

therapies

for long-term treatment…once the traditional therapies have been

exhausted. "

Tysabri, he says, " represents a significant advance in providing a new

therapeutic option to patients who clearly need options. "

The goals of treating Crohn's patients, says Rhonda Letwin, director

of

product development at Walgreens Specialty Pharmacy and a registered

nurse,

are to achieve remission and then to maintain remission, which often

can be

done with 5-ASAs, immunosuppressives and corticosteroids. But some

patients'

conditions keep progressing in their severity, she says, and they

need to

use a biologic therapy.

" The fact that Tysabri was approved brings renewed attention to this

disease, " says Cichy. " It has improved the pharmacologic options. "

But it

has also increased the price tag for treating Crohn's, he says. The

cost per

patient per year on Remicade (infliximab) is approximately $20,000 to

$22,000, he says. Although Cichy says he is not privy to the final

pricing

for Tysabri's new indication, " if the price point for multiple

sclerosis is

any indication, this will be expensive. " A Biogen Idec spokesperson

confirms

that the new Crohn's pricing will be consistent with the $28,968

wholesale

acquisition cost of the MS indication.

" This is extending the price tag for Crohn's, as [Tysabri] is now the

most

expensive product in the category, " says Cichy. And, he adds, not

only will

the price within the infusion category increase, but also " the

average cost,

including orals, will move significantly to the right. "

*Crohn's Situation Similar to Rheumatoid Arthritis'*

Benefit design challenges exist as well, according to Cichy. With

Tysabri's

approval, Crohn's is looking " increasingly similar to the situation

facing

rheumatoid arthritis, " he asserts. Crohn's treatments include oral,

injectable and infusible drugs. They can be administered by a

physician in

an office or self-administered by a patient at home, and they can be

obtained by a physician or by a patient through the retail channel.

There

are also multiple products within categories. Similar to rheumatoid

arthritis, there are variations in benefit design — the drugs may

fall under

either the pharmacy or the medical benefit — and in the distribution

channel.

Because drugs under the medical benefit are designated by J-codes,

which

indicate only the drug used and not the indication, it can be a

challenge

for plans to track which drugs are used for what condition, says

Debbie

Stern, vice president of consulting firm Rxperts, Inc. This can be

important, for example, in situations where plans may need to compare

the

usage of drugs within a therapeutic class to receive a rebate from a

manufacturer. " Some plans don't have the ability to delve into their

medical

claims data, " she says. " If they do, they may not have the data to

know the

diagnosis code. "

The array of therapies requires payers to closely coordinate benefit

designs, according to Cichy, who adds that plans should be aware of

the

potential differential of copayments and coinsurance. For example, a

patient

on an infusible therapy might pay a minimal out-of-pocket amount for a

doctor's visit at which he or she is treated, whereas a patient

buying a

self-administered drug might be paying substantially more for his or

her

therapy.

While product preferencing may occur among some of the comparable

rheumatoid

arthritis therapies, in Crohn's such an approach would

be " complicated on

the basis that Tysabri has a risk-map program and labeling that is

fairly

rigid compared to Remicade, " says Cichy. " The opportunity to

rigorously

enforce preferred products on a formulary may be limited. It is

different

than in rheumatoid arthritis, where you don't have products

associated with

a risk-map program, and have various self-administered products. "

*Reprinted from **SPECIALTY PHARMACY

NEWS*<http://www.aishealt h.com/Products/ NewsSPN.html>

*, a monthly newsletter designed to help health plans, PBMs,

providers and

employers manage costs more aggressively and deliver biotechs and

injectables more effectively. *

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Combined immunosuppression (CI) therapy is more effective than

conventional

treatment using corticosteroids for inducing remission in and

management of

patients recently diagnosed with Crohn's disease. Using intensive

immunosuppressive therapy early in the course of the disease could

result in

better outcomes. These are the conclusions of authors of an Article

in this

week's edition of *The Lancet*.

Current practice guidelines recommend that most patients with active

Crohn's

disease should be treated initially with corticosteroids. Although

this

approach is usually effective for control of symptoms, many patients

become

resistant to, or dependent on, these drugs. Long exposure to

corticosteroids

is also associated with the complications of Cushing's syndrome and,

therefore, an increased risk of mortality.

Dr. Geert D'Haens, Imelda Gastrointestinal Clinical Research Centre,

Imelda

General Hospital, Bonheiden, Belgium, and colleagues conducted a 2-

year,

open-label, randomised trial of 133 patients at 18 centres in Belgium,

Holland, and Germany. The 67 patients assigned to CI received three

infusions of infliximab (5 mg/kg of bodyweight) at weeks 0, 2, and 6,

with

azathioprine. Additional treatment with infliximab and, if necessary,

corticosteroids, was given to control disease activity. The 66

patients

assigned to conventional management received corticosteroids,

followed, in

sequence, by azathioprine and infliximab. The primary outcome

measures of

the study were remission without corticosteroids and without bowel

resection

at weeks 26 and 52.

The researchers found that, at week 26, 60.0% of the patients in the

CI

group were in remission without corticosteroids and without surgical

resection, compared with 35.9% in the conventional management group.

By week

52, the corresponding rates were 61.5% in the CI group and 42.2% in

the

conventional therapy group. Proportions of patients having serious

adverse

events were similar in both groups -- 30.8% in the CI group, 25.3% in

the

conventional therapy group.

The authors conclude: " Combined immunosuppression was more effective

than

conventional management for induction of remission and reduction of

corticosteroid use in patients who had recently been diagnosed with

Crohn's

disease. Initiation of more intensive treatment early in the course

of the

disease could result in better outcomes. "

In an accompanying Comment, Dr Sandborn, Inflammatory Bowel

Disease

Clinic, Mayo Clinic, Rochester, Minn, USA, says that results from

another

further study in this area -- the SONIC (Study of Biologic and

Immunomodulator Naïve Patients in Crohn's Disease) trial -- are

eagerly

awaited. They are due in the second half of 2008. " If the preliminary

data

on initial combination therapy in early Crohn's disease reported by

D'Haens

and colleagues are confirmed, " he says, " the treatment algorithm for

patients with Crohn's disease will change. "

SOURCE: *The Lancet*

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jeff,

pg,

cd